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CompliantPro

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COMPLIANTPRO™

 

CompliantPro is a robust, extremely flexible, web-based compliance management software system for proactively managing compliance to a variety of regulations and standards. The software provides the core functionality to manage processes for communicating, monitoring and documenting your diverse compliance activities. CompliantPro makes compliance-related information easily accessible to everyone involved in your processes, in real time. It transcends organizational silos, eliminating inconsistency and duplication of effort to streamline compliance processes, and minimize time, complexity and cost.

CompliantPro offers a unique combination of features including:

Flexible Workflows

CompliantPro is easily configured for your organization’s process workflows and meets the needs of specific standards and regulations. CompliantPro conforms to your processes…not the other way around.

Personalized Dashboard

You have a personalized dashboard presenting only the information and tasks relating to your specific roles and responsibilities. At a glance, you can see what needs your attention. Real-time tracking gives you immediate feedback on the status of your documents and tasks.

Scalable and Extensible

Based on a flexible, modular architecture, the system is suitable for one location or global operations of any size. Initial setup is efficient and centralized, resulting in rapid deployment and fast ramp-up. True multilingual capability makes CompliantPro ideal for international organizations.

Platform- and Location-independent

As a web-based system, CompliantPro can be accessed from virtually anywhere using a standard web browser. This enables true, enterprise-wide compliance management, cutting across departments, business units and organizations.

Alerts and Escalation

CompliantPro automatically sends alerts to remind users of impending deadlines and escalation messages to management when deadlines have been missed.

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Managing the entire compliance cycle.

CompliantPro provides integrated elements for managing all of your compliance management requirements:

Document Control

Corrective and Preventative Action (CAPA)

CompliantProMD for Medical Device Manufacturers

Assessments

Training and Qualification

Calibration and Preventative Maintenance Management

Enterprise Risk Management

Sarbanes Oxley Process Management

Environmental Management

Occupational, Health and Safety

Customer Management

Supplier Management

 

Document Control

Effective document control is at the heart of any compliance management system. CompliantPro provides a flexible framework for creating, modifying, versioning, approving, releasing and archiving all compliance documents. Configure document Review and Approval workflow to meet your specific requirements. Choose up to three levels of escalation and up to five back-up approvers per approver. Create new document types with the click of a button. Automated email notifications are sent to approvers and recipients at every stage.

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Corrective and Preventative Action (CAPA)

With CompliantPro compliance software, you can rapidly identify, analyze and address compliance-related deficiencies. Easily generate Corrective Action Requests (CARs) and Preventative Action Requests (PARs), with links to multiple issues or concerns. Configure CAR and PAR workflow to meet your unique requirements. Track status of CARs in real time, from draft to resolution and final review. The system alerts users to pending due dates and escalates overdue items.

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CompliantProMD for Medical Device Manufacturers

Our software has special capabilities designed to help medical device manufacturers build comprehensive quality systems, as mandated by the FDA and ISO. CompliantProMD has built-in features for managing Device Master Records and associated documents, performing assessments, corrective and preventative actions, complaint management, and other quality requirements. The software also has unique capabilities for risk management, which allow users to integrate compliance initiatives for ISO 14971 and ISO 13485. CompliantProMD is compliant with FDA 21 CFR Part 11 and 820, and IBS offers a full range of validation services.

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Assessments

CompliantPro helps organizations effectively audit processes to ensure compliance with relevant standards and regulations. Internal assessments and supplier assessments are scheduled, created and executed online. Create CARs from assessment findings when non-conformances are identified.

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Training and Qualification

CompliantPro includes a single, powerful repository for employee training and certification information, including course information, job requirements and employee training profiles. Employees can self-acknowledge completion of training, triggering automatic email notification to their supervisors, who can then automatically update trainee records. Automatic alerts are provided for key training/qualification events, such as expiring certifications and revised training requirements.

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Calibration and Preventative Maintenance Management

Perform efficient gage and equipment control with the CompliantPro Calibration and Preventative Maintenance Management module. Create detailed schedules for all your calibration and equipment maintenance activities. Ensure that you meet your deadlines with our automated notifications, alerts and escalation. Take advantage of the system's matchless flexibility and tailor forms to your specific needs - without programming! Achieve your calibration management goals with our comprehensive web-based compliance management software.

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Enterprise Risk Management

Now foresight can be 20/20. CompliantPro's Enterprise Risk Management solution helps you assess and mitigate risks that can damage your business value. Perform thorough risk analysis and controls testing. Restructure company-wide communications. Achieve your risk management goals, whether it's compliance with SOx, ISO/IEC 27002:2005 (ISO/IEC 17799:2005), Basel II or AUS/NZS 4360, or rollout of compliance frameworks like OCEG "Red Book" and COSO ERM.

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Sarbanes Oxley Process Management

Consumed by the effort and expense of complying with Sarbanes Oxley? Discover our streamlined, cost-effective solution for SOx process management. CompliantPro enables you to address the requirements of SOx sections 302, 404, and 409. You'll simplify financial reporting and monitoring, document process and controls, and perform thorough risk assessment. Take our holistic approach to your compliance efforts, and manage your next audit with confidence.

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Environmental Management

Transform your approach to environmental management. The CompliantPro Environmental Management system fosters compliance with a range of standards, including the ISO 14001:2004 Environmental Management System Standard. Improve environmental record-keeping. Analyze your environmental Aspects and Impacts. Develop and track your environment targets and objectives. You'll see long-term, significant results - like a safer, more positive workplace, higher productivity, and lower compliance costs.

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Occupational, Health & Safety

Create the complete occupational, health and safety system. Track and address workplace incidents, monitor safety hazards and controls, and effectively manage your policies and records. CompliantPro is the most agile compliance software available for compliance with Occupational Health and Safety Standards such as OHSAS 18001, BS8800, and ANSI/AIHA Z10-2005.

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Customer Management

Drive lasting customer satisfaction when you integrate customer management and quality. CompliantPro enables you to better manage your customer relationships. Assess popular opinion about your products. Build customer suggestions and complaints into your product and process planning and improvement. You'll increase marketability while improving product quality.

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Supplier Management

Achieve better product quality when you perform effective Supplier Management. CompliantPro helps you perform supplier assessments and evaluations, identify issues with outsourced parts and products, and move them quickly to resolution. You'll strengthen supplier relationships while maximizing your outsourcing investment.

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The CompliantProTM product is supplied by IBS in the United States of America. www.ibs-us.com

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